Notification Detail

Draft Order supplementing the Order of 23 March 2020 prescribing the organisational and operational health system measures necessary to deal with the COVID-19 epidemic in the context of the state of health emergency

Notification Number: 2020/253/F (France )
Date received: 23/04/2020
End of Standstill: 06/05/2020
Invocation of the Emergency Procedure: Yes

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Message 002

Communication from the Commission - TRIS/(2020) 01484
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2020/0253/F

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 202001484.EN)

1. Structured Information Line
MSG 002 IND 2020 0253 F EN 23-04-2020 F NOTIF


2. Member State
F


3. Department Responsible
Direction générale des entreprises – SQUALPI – Bât. Sieyès -Teledoc 151 – 61, Bd Vincent Auriol - 75703 PARIS Cedex 13
d9834.france@finances.gouv.fr
tél : 01 44 97 24 55


3. Originating Department
Direction des affaires juridiques du ministère des solidarités et de la santé
14, avenue Duquesne 75007 PARIS
Secrétariat : 01 40 56 65 57/56 95
daj-sec@sg.social.gouv.fr


4. Notification Number
2020/0253/F - C10P


5. Title
Draft Order supplementing the Order of 23 March 2020 prescribing the organisational and operational health system measures necessary to deal with the COVID-19 epidemic in the context of the state of health emergency


6. Products Concerned
proprietary products containing nicotine


7. Notification Under Another Act
-


8. Main Content
In view of the health situation and until 31 May 2020, the draft text provides that:

- pharmacy dispensing of proprietary products containing nicotine that are used in the treatment of tobacco dependence shall be limited to the number of boxes required for a treatment lasting one month.
- the number of boxes dispensed shall be entered in the pharmaceutical file, whether or not the patient has presented a medical prescription.
- all Internet sales of these proprietary products are hereby suspended.


9. Brief Statement of Grounds
The World Health Organization (WHO) declared that the emergence of a novel coronavirus (COVID-19) constitutes a public health emergency of international concern on 30 January 2020.

Because of media coverage of the potentially protective effect of nicotine against COVID-19, there is a high risk of a significant rise in the pharmacy dispensing and Internet sale of nicotine replacement treatments over the coming days.

It is thus necessary to regulate the pharmacy dispensing and Internet sale of nicotine substitutes, firstly to prevent the health risks associated with excessive consumption or misuse in the wake of media coverage of the potentially protective effect of nicotine against COVID-19 and, on the other hand, to guarantee a continuous and appropriate supply for people requiring medicinal support in the context of quitting smoking.

The draft text complies with Directive 2000/31, known as the Directive on electronic commerce, and in particular Article 3(5) thereof.


10. Reference Documents - Basic Texts
Reference(s) to basic text(s): Article L3131-16 of the Public Health Code


11. Invocation of the Emergency Procedure
Yes


12. Grounds for the Emergency
Emergency measure to protect the population against the serious health threat posed by the COVID-19 novel coronavirus.


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
-


16. TBT and SPS aspects
TBT aspect

No - the draft has no significant impact on international trade.

SPS aspect

No - the draft is neither a sanitary nor phytosanitary measure.

**********
European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu

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